The effect of different doses of cyclosporin A on the systemic exposure of orally administered paclitaxel

Anti-Cancer Drugs

Volumn 12, Issue 4, 2001, Pages 351-358

  Malingré, Mirte M ^a   Beijnen, Jos H ^a,b   Rosing, Hilde ^a   Koopman, Franciska J ^a   Van Tellingen, Olaf ^a   Duchin, Ken ^c   Ten Bokkel Huinink, Wim W ^a   Swart, Martha ^a   Lleverst, Jan ^a   Schellens, Jan H M ^a,b  

^a SLOTERVAART HOSPITAL   (Netherlands)

^b UTRECHT UNIVERSITY   (Netherlands)

^c Baker Norton Pharmaceuticals Inc   (United States)

Author keywords

Cyclosporin A; Oral administration; Paclitaxel

Indexed keywords

CYCLOSPORIN A; PACLITAXEL;

ADENOCARCINOMA; ADULT; AGED; ALOPECIA; ANEMIA; ARTICLE; BREAST CANCER; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG EFFECT; DRUG EXPOSURE; FATIGUE; FEMALE; GRANULOCYTOPENIA; HUMAN; LEUKOPENIA; LUNG NON SMALL CELL CANCER; MALE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STATISTICAL ANALYSIS; STOMACH CANCER; UTERINE CERVIX CANCER;

ADENOCARCINOMA; ADMINISTRATION, ORAL; ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; AREA UNDER CURVE; BREAST NEOPLASMS; CARCINOMA, SMALL CELL; CYCLOSPORINE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; GASTROINTESTINAL DISEASES; HEMATOLOGIC DISEASES; HUMANS; INFUSIONS, INTRAVENOUS; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEOPLASMS; PACLITAXEL; PREMEDICATION; STOMACH NEOPLASMS; UTERINE CERVICAL NEOPLASMS; UTERINE NEOPLASMS;

EID: 0035023669     PISSN: 09594973     EISSN: None     Source Type: Journal    
DOI: 10.1097/00001813-200104000-00008     Document Type: Article

References (35)

1. 1. Rowinsky EK, Donehower RC. Paclitaxel (Taxol). N Engl J Med 1995; 332: 1004-14.
2. 2. Huizing MT, Sewberath Misser VH, Pieters RC, et al. Taxanes: a new class of antitumor agents. Cancer Invest 1995; 13: 381-404.
3. 3. Sparreboom A, Van Asperen J, Mayer U, et al. Limited oral bioavailability and active epithelial secretion of paclitaxel caused by P-glycoprotein in the intestine. Proc Natl Acad Sci USA 1997; 94: 2031-5.
4. 4. Van Asperen J, Van Tellingen O, Sparreboom A, et al. Enhanced oral bioavailability of paclitaxel in mice co-treated with the P-glycoprotein blocker SDZ PSC 833. Br J Cancer 1997; 76: 1181-3.
5. 5. Van Asperen J, Van Tellingen O, Van der Valk MA, Rozenhart M, Beijnen JH. Enhanced oral absorption and decreased elimination of paclitaxel in mice co-treated with cyclosporin A. Clin Cancer Res 1998; 4: 2293-7.
6. 6. Meerum Terwogt JM, Beijnen JH, ten Bokkel Huinink WW, Rosing H, Schellens JHM. Co-administration of cyclosporin enables oral therapy with paclitaxel. Lancet 1998; 352: 285.
7. 7. Meerum Terwogt JM, Malingré MM, Beijnen JH, et al. Co-administration of cyclosporin A enables oral therapy with paclitaxel. Clin Cancer Res 1999; 5: 3379-84.
8. 8. Kelland LR, Abel G. Comparative in vitro cytotoxicity of Taxol and Taxotere against cisplatin-sensitive and -resistant human ovarian carcinoma cell lines. Cancer Chemother Pharmacol 1992; 30: 444-50.
9. 9. Liebmann JE, Cook JA, Lipschultz C, Teague D, Fisher J, Mitchell JB. Cytotoxic studies of paclitaxel (Taxol) in human tumour cell lines. Br J Cancer 1993; 68: 1104-9.
10. 10. Lopes NM, Adams EG, Pitts TW, Bhuyan BK. Cell kill kinetics and cell cycle effects of Taxol on human and hamster ovarian cell lines. Cancer Chemother Pharmacol 1993; 32: 235-42.
11. 11. Baguley BC, Marshall ES, Whittaker JR, et al. Resistance mechanisms determining the in vitro sensitivity to paclitaxel of tumour cells cultured from patients with ovarian cancer. Eur J Cancer 1995; 31: 230-7.
12. 12. Raymond E, Hanauske A, Faivre S, et al. Effects of prolonged versus short-term exposure paclitaxel (Taxol) on human tumor colony-forming units. Anti-Cancer Drugs 1997; 8: 379-85.
13. 13. Huizing MT, Keung AC, Rosing H, et al. Pharmacokinetics of paclitaxel and metabolites in a randomized comparative study in platinum-pretreated ovarian cancer patients. J Clin Oncol 1993; 11: 2117-35.
14. 14. Gianni L, Kearns CM, Giani A, et al. Nonlinear pharmacokinetics and metabolism of paclitaxel and its pharmacokinetic/pharmacodynamic relationships in humans. J Clin Oncol 1995; 13: 180-90.
15. 15. Ohtsu T, Yasutsuna S, Tamura T, et al. Clinical pharmacokinetics and pharmacodynamics of paclitaxel: a 3-hour infusion versus a 24-hour infusion. Clin Cancer Res 1995; 1: 599-606.
16. 16. Huizing MT, Giaccone G, Van Warmerdam LJC, et al. Pharmacokinetics of paclitaxel and carboplatin in a dose-escalating and sequencing study in patients with non-small cell lung cancer. J Clin Oncol 1997; 15: 317-29.
17. 17. Malingré MM, Meerum Terwogt JM, Beijnen JH, et al. Phase I and pharmacokinetic study of oral paclitaxel. J Clin Oncol 2000; 18: 2468-75.
18. 18. Malingré MM, Beijnen JH, Rosing H, et al. A phase I and pharmacokinetic study of bi-daily dosing of oral paclitaxel in combination with cyclosporin A. Cancer Chemother Pharmacol, in press
19. 19. Kahan BD. Cyclosporine. N Engl J Med 1989; 321: 1725-38.
20. 20. Myers BD, Ross J, Newton L, Luetscher J, Perlroth M. Cyclosporine-associated chronic nephropathy. N Engl J Med 1984; 311: 699-705.
21. 21. Dye D, Watkins J. Suspected anaphylactic reaction to Cremophor EL. Br Med J 1980; 280: 1353.
22. 22. Guidelines for reporting of adverse drug reactions. Bethesda, MD: National Cancer Institute, Division of Cancer Treatment 1988.
23. 23. WHO handbook for reporting results of cancer treatment. Geneva: WHO 1979.
24. 24. Chan GL, Weinstein SS, Lefor WW, Spoto E, Kahana L, Shires DL. Relative performance of specific and non-specific fluorescence immunoassay for cyclosporin in transplant patients. Ther Drug Monit 1992; 14: 42-7.
25. 25. Huizing MT, Sparreboom A, Rosing H, Van Tellingen O, Pinedo HM, Beijnen JH. Quantification of paclitaxel metabolites in human plasma by high-performance liquid Chromatography. J Chromatogr B 1995; 674: 261-8.
26. 26. Sparreboom A, Van Tellingen O, Huizing MT, Nooijen WJ, Beijnen JH. Determination of polyoxyethyleneglycerol triricinoleate 35 (Cremophor EL) in plasma by pre-column derivatization and reversed-phase high-performance liquid chromatography. J Chromatogr B 1996; 681: 355-62.
27. 27. Van Tellingen O, Huizing MT, Nannan Panday VR, Schellens JHM, Nooijen WJ, Beijnen JH. Cremophor EL causes (pseudo)non-linear pharmacokinetics of paclitaxel in patients. Br J Cancer 1999; 81: 330-5.
28. 28. Huizing MT, Rosing H, Koopman FJ, Keung ACF, Pinedo HM, Beijnen JH. High-performance liquid chromatographic procedures for the quantitative determination of paclitaxel (Taxol) in human urine. J Chromatogr B 1995; 664: 373-82.
29. 2 as a 3-hour infusion. Clin Drug Invest 1995; 9: 344-53.
30. 30. Gibaldi M, Perrier D. Noncompartmental analysis based on statistical moment theory. In: Swarbrick J, ed. Pharmacokinetics. New York, NY: Marcel Dekker 1982: 409-17.
31. 31. Cresteil T, Monsarrat B, Alvinerie P, Treluyer JM, Vieira I, Wright M. Taxol metabolism by human liver microsomes: identification of cytochrome P450 isozymes involved in its biotransformation. Cancer Res 1994; 54: 386-92.
32. 32. Monsarrat B, Mariel E, Cros S, et al. Taxol metabolism. Isolation and identification of three major metabolites of taxol in rat bile. Drug Metab Disp 1990; 18: 895-901.
33. 33. Shet MS, Fisher CW, Holmans PL, Estabrook RW. Human cytochrome P450 3A4: enzymatic properties of a purified recombinant fusion protein containing NADPH-P450 reductase. Proc Natl Acad Sci USA 1993; 90: 11748-52.
34. 34. Sparreboom A, Van Tellingen O, Nooijen WJ, Beijnen JH. Nonlinear pharmacokinetics of paclitaxel in mice results from the pharmaceutical vehicle Cremophor EL. Cancer Res 1996; 56: 2112-5.
35. 35. Sparreboom A, Van Tellingen O, Nooijen WJ, Beijnen JH. Tissue distribution, metabolism and excretion of paclitaxel in mice. Anti-Cancer Drugs 1996; 7: 78-86.